Compared with placebo, anifrolumab was found to demonstrate robust efficacy in patients with moderate to severe systemic lupus erythematosus (SLE), according to research presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to 13, 2019, in Atlanta, Georgia.
Patients were eligible for the study if they met ACR SLE criteria and had an SLE Disease Activity Index (SLEDAI)-2K score ≥6 and a British Isles Lupus Assessment Group (BILAG) index A score ≥1 or B score ≥2. The primary end point was achievement of BILAG-Based Composite Lupus Assessment (BICLA) response at week 52. Standard of care was stable, with the exception of tapering of oral corticosteroids to a prednisone equivalent ≤7.5 mg/d in patients receiving ≥10 mg/d at baseline.
A total of 362 patients received either ≥1 dose of anifrolumab 300 mg intravenously (n=180) or placebo (n=182) every 4 weeks for 48 weeks. Baseline demographics and disease characteristics were similar between the 2 groups; 85.5% of patients in the anifrolumab group completed treatment compared with 71.4% of those in the placebo group.
Anifrolumab was found to be superior to placebo both in BICLA response (47.8% vs 31.5%, respectively; P=.001) and in meeting key secondary end points, including oral corticosteroid reduction and the Cutaneous Lupus Erythematosus Disease Area and Severity Index response. Annualized flare rates were lower in patients who received anifrolumab compared with those who received placebo (0.64 vs 0.43, respectively; rate ratio, 0.67; 95% CI, 0.48-0.94; P=.081).